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Associate Director - Regulatory Affairs

Facility:  Regulatory
Location: 

Plainsboro, NJ, US

About the Department                                                                                                                                               

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the Food & Drug Administration (FDA) to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

Oversee all assigned projects/products/processes. Assist the Director/Senior Director in assuring Novo Nordisk compliance with internal Standard Operating Procedures (SOPs) and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies. Act as liaison with FDA for assigned projects.

 

Relationships

Report to the Senior Director Regulatory Affairs. Interact with key company personnel both within and outside of Novo Nordisk-US as related to assigned projects. Develop and maintain positive rapport and working relationships with other personnel in Regulatory Affairs, CMR, and other local and headquarter departments in support of initiatives and to accomplish company goals. FDA liaison for designated projects or as requested by supervisor.

 

Essential Functions

  • Therapeutic Area
    • Act as liaison with Novo Nordisk Inc (NNI) and Novo Nordisk AS (NNAS) departments for preparation of documentation necessary for submission of applications
    • Approve specified regulatory submissions
    • Assist senior Regulatory Affairs personnel in assuring compliance
    • Coordinate and supervise the development of regulatory strategies for new or modified pharmaceutical products and for 510(k) devices under development or license for assigned projects
    • Facilitate and organize the compilation of applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications
    • FDA liaison on key matters
    • Identify the need for and provide input into development of systems for assigned projects for the efficient operation of the department
    • Lead FDA meetings
    • Lead major label negotiations
    • Manage complex projects
    • May act as FDA liaison for all project issues
    • May act as Global Regulatory Team (GRT) member
    • Participate in and/or coordinate all negotiations and interacts with FDA personnel as assigned
    • Provide information and training for NNAS in areas of IND, NDA, and 501(k) processes. Disseminate information on proposed and new FDA regulations and guidelines for assigned products/projects
    • Provide input into development of regulatory and quality systems
    • Provide input into development of Standard Operating Procedures (SOPs) for the efficient operation of the department and inter-department activities
    • Provide training to the regulatory staff and Sales Reps as needed
    • Responsible for development of regulatory submission strategies
    • Review data from contributing departments (including NNAS) and provide comments to assure accurate and complete documents for inclusion in these applications
    • Submit all types of applications to FDA
    • Supervise and advise staff members
    • Supervise and coordinate all regulatory activities relating to regulatory compliance for assigned marketed and investigational products
    • Supervise and coordinate the planning of FDA submissions for assigned products/projects to ensure most efficient use of resources
    • Supervise the review and sign-off on all labeling for marketed products prior to use for assigned products/projects

 

Physical Requirements

0-10% overnight travel required. Novo Nordisk requires all employees, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine by November 15, 2021. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation for those unable to be vaccinated. You will be required to upload an image of your COVID-19 vaccine card at the time of hire and/or on your first day of employment.

 

Qualifications

  • A Bachelors required/Advance degree preferred; Life Science degree preferred; expertise in project area/s preferred
  • A minimum of 8 years total pharmaceutical/related industry experience required
  • A minimum 6 years regulatory experience
  • Project management experience required, supervisory experience strongly preferred
  • Ability to establish sound working relationships
  • Ability to work independently
  • Detail & deadline oriented; well organized
  • Excellent verbal and written communication skills essential
  • Experience and knowledge of the relevant current requirements of FDA required
  • For global projects, prior interaction or exposure with other key regulatory authorities e.g. EMEA, EU national authorities, PMDA
  • Good interpersonal skills; ability to interact with staff on all levels

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

Novo Nordisk is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

 

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.